MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients (ACRIN 6651)

January 25, 2013 updated by: American College of Radiology Imaging Network

Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer

RATIONALE: Imaging procedures such as MRI or CT scans may improve the ability to detect cervical cancer and determine the extent of disease.

PURPOSE: Diagnostic trial to determine the effectiveness of MRI and CT scans in evaluating invasive cervical cancer before treatment of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the diagnostic performance of magnetic resonance imaging (MRI), computed tomography (CT), and clinical FIGO staging in patients with invasive cervical cancer.
  • Compare the accuracy of MRI, CT, and clinical FIGO staging in the evaluation of morphologic tumor prognostic factors in FIGO stage IB1 and stage IB2 and greater in these patients.
  • Examine the value of imaging assessment of tumor prognostic factors (alone or in combination) as predictors of recurrence within 2 years of surgery in these patients.
  • Evaluate the quality of life in the 12-month period after staging and treatment to potentially change staging accuracy.

OUTLINE: This is a multicenter study.

Patients undergo a computed tomography scan with iodinated contrast dye followed by a magnetic resonance imaging scan with or without contrast comprising gadopentetate dimeglumine or vice versa.

Within 6 weeks of first protocol imaging study, patients undergo one of the following surgeries:

  • Laparoscopic, transabdominal, or transvaginal hysterectomy
  • Extrafascial total abdominal hysterectomy
  • Trachelectomy Quality of life is assessed at 1 and 12 months.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 465 patients will be accrued for this study within 18 months.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07962-1956
        • Morristown Memorial Hospital
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive cervical cancer, including invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma

    • FIGO stage IB1 with clinically visible gross lesion OR
    • FIGO stage IB2 or greater

  • Scheduled for one of the following surgeries at a participating Gynecological Oncology Group center:

    • Laparoscopic, transabdominal, or transvaginal hysterectomy
    • Extrafascial total abdominal hysterectomy
    • Trachelectomy
  • Not scheduled for a loop electrosurgical excision procedure or a cone biopsy only

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No cardiac pacemakers

Pulmonary:

  • No asthma

Other:

  • Not pregnant
  • No contraindication to computed tomography (CT) (e.g., history of allergy to CT contrast medium)
  • No contraindication to magnetic resonance imaging (e.g., intracranial vascular clip)
  • No nonmalignant general medical or psychiatric condition that would preclude consent or surgery

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for invasive cervical cancer

Surgery:

  • See Disease Characteristics
  • No prior surgery for invasive cervical cancer

Other:

  • No prior medical treatment for invasive cervical cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American College of Radiology Imaging Network

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Hedvig Hricak, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Actual)

May 1, 2001

Study Completion (Actual)

October 1, 2002

Study Registration Dates

First Submitted

March 7, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067622
  • CA80098 (Other Grant/Funding Number: NCI CIP)
  • ACRIN-6651
  • GOG-183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

Clinical Trials on computed tomography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe